Position: Vice President, Non-Clinical Safety & Toxicology

Reporting to: Chief Scientific Officer

Location: San Diego, CA

COMPANY BACKGROUND

This global pharmaceutical organization is dedicated to advancing treatments for multiple endocrine related diseases. The company specializes in discovering, developing, and commercializing innovative therapies, with a strong focus on small molecules designed for precise pharmacological effects. Founded by a team of scientists committed to rigorous innovation, the company operates from its headquarters in California and aims to improve lives through better therapies.

Its flagship product has been approved by the FDA for a metabolic disease, with ongoing development for additional indications. The pipeline includes more than ten programs, featuring early and late-stage candidates addressing conditions such as adrenal and pituitary disorders, thyroid disease, polycystic kidney disease, diabetes, obesity, and oncology. Backed by a robust discovery engine, proven clinical results, and significant financial resources, the company is positioned for continued growth and aspires to become a global leader in endocrine-focused medicine.

POSITION SUMMARY

Reporting to the Chief Scientific Officer, the Vice President of Nonclinical Drug Safety and Toxicology is a key position within the R&D leadership team and will lead key nonclinical aspects of all the company’s pipeline programs. As the senior-most toxicology expert within the organization, the VP will oversee a team of in-house and external toxicologists and will be responsible for providing strategic and operational leadership for the toxicology group across the portfolio of discovery, early development, and late development programs. As the Non-Clinical Safety and Toxicology group operates as a “center of excellence” within the R&D organization, this leader will partner cross-functionally across therapeutic areas with colleagues in drug discovery, translational, and clinical development functions, ensuring toxicology and nonclinical safety data is shared and communicated transparently and plays a role in informing strategy at all stages of each program’s development.

KEY RESPONSIBILITIES

Areas of specific responsibility and attention will include the following:

• Create a long-term global toxicology strategy in alignment with the company’s vision and objectives, including multi-year scientific and operational plans.

• Lead scientific direction for global regulatory toxicology including safety pharmacology.

• Lead scientific direction for safety assessments of discovery and early development programs, aligning with program objectives and regulatory strategies.

• Oversee toxicology findings and provide advice to project teams and senior management on potential impact of results on program goals and probability of success.

• Collaboratively design and implement external toxicity studies (in vitro and in vivo) required for lead optimization, and development candidate selection.

• Develop strategy, plan and budget to effectively manage regulatory toxicity studies (in vitro and in vivo) required for IND and NDA submissions, including general toxicity, juvenile toxicity, genotoxicity, safety pharmacology, reproductive and developmental, and carcinogenicity studies.

• Work with internal R&D leaders and external parties including development partners, consultants, CROs and approved vendors based on a balance of quality, timeliness, and cost.

• Hire, lead, and direct the scientific and operational toxicology teams to effectively meet deadlines and organizational objectives.

• Develop and manage of timelines related to this function.

• Identify and engage experts in the field of toxicology (e.g., consultants) to interpret study results and make recommendations, as needed.

• Communicate toxicity study results to discovery program and development teams, and to the company’s executive management and Board of Directors, as needed.

• Actively participate in regulatory meetings.

• Other duties as assigned.

PROFESSIONAL EXPERIENCE/QUALIFICATIONS

• PhD in toxicology or related discipline with at least 15 years of experience, (an equivalent combination of experience and education may be considered) with at least 14 years of leadership/supervisory experience.

• Preferred 10 years of experience managing and developing a drug safety/toxicology team.

• DABT certification strongly preferred.

• Experience in defining and implementing scientifically relevant and compliant nonclinical toxicology strategies and contingency plans addressing both theoretical and identified nonclinical safety issues.

• Collaborative mindset capable of excelling within multi-discipline discovery and development teams

• Proven track record of interfacing with global regulatory authorities, and the design and interpretation of safety studies for regulatory submissions, including INDs and NDAs.

• Deep knowledge of FDA and EMA requirements and guidance for nonclinical safety submissions.

• Strong communication (written and oral) and interpersonal skills with an ability to effectively function within a matrixed environment.

EDUCATION

• PhD in toxicology or related discipline with at least 15 years of experience, (an equivalent combination of experience and education may be considered) with at least 14 years of leadership/supervisory experience.

• Preferred 10 years of experience managing and developing a drug safety/toxicology team.

COMPENSATION

• An attractive and competitive compensation package to include base salary, bonus, and equity participation.

TRAVEL

• Travel may be required up to 5% of your time.

VACCINATION REQUIREMENT

• Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, the company requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.